|Clinical and Regulatory|
|Event Type:||Phase 2 Results|
This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
|Disease and Treatment|
|Indication:||Atypical Hemolytic Uremic Syndrome (aHUS)|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
Orphan and Rare Diseases:
- Evaluate formal feedback from End of Phase II and scientific advice meetings with U.S. and EU regulatory agencies and formalize the CCX168 AAV Phase III development plan in the second half of 2016;
- Initiate Phase III development program with CCX168 for the treatment of AAV by the end of 2016; and
- Report early results from the Phase II pilot study of CCX168 in aHUS patients who are on dialysis in late 2016.